Dasatinib + Ropeginterferon for Chronic Myeloid Leukemia

Overseen By Fadi Haddad, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must be taking: TKI

Must not be taking: Investigational agents

Disqualifiers: Cardiac disease, Autoimmune disease, Depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of two drugs, dasatinib (a tyrosine kinase inhibitor) and ropeginterferon (a form of interferon therapy), to determine if they can better control chronic myeloid leukemia (CML) in its early stages. The study also evaluates the safety of these drugs when used together. People with CML in the chronic phase who have not extensively used certain previous treatments might be suitable candidates for this trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss your specific medications with the trial team to get a clear answer.

Is there any evidence suggesting that this treatment combination is likely to be safe for humans?

Research has shown that using dasatinib and ropeginterferon together is generally safe for people with chronic myeloid leukemia (CML). Studies have found that these drugs can effectively work together to control the disease. Patients in previous trials tolerated these treatments well in terms of safety.

Some side effects to be aware of include low blood cell counts and flu-like symptoms, which are common with these types of drugs. However, most patients manage these side effects with proper care. Overall, the combination of dasatinib and ropeginterferon appears to be a promising and safe option for treating CML. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of Dasatinib and Ropeginterferon for treating Chronic Myeloid Leukemia (CML) because it brings unique features to the table. Unlike standard treatments like Imatinib, which primarily target specific proteins, Dasatinib works by inhibiting multiple proteins involved in cancer cell growth, potentially making it more effective. Ropeginterferon adds another layer by boosting the body’s immune response against cancer cells, which isn't a common approach in existing CML treatments. This dual-action strategy could lead to more comprehensive disease control and improved patient outcomes.

What evidence suggests that this trial's treatments could be effective for chronic myeloid leukemia?

Studies have shown that combining dasatinib and ropeginterferon effectively treats chronic myeloid leukemia (CML). This trial will evaluate how these two drugs work together to attack leukemia cells and boost the immune system. Research indicates that this combination can significantly reduce the number of leukemia cells in the body. Initial findings suggest this treatment could be a promising option for managing CML. ^{1 2 4 5 6}

Who Is on the Research Team?

Fadi Haddad, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

Adults over 18 with newly diagnosed Chronic Myeloid Leukemia in chronic phase can join. They may have had limited prior treatment, must not have severe heart issues (NYHA class II or better), and need good liver and kidney function. HIV-positive patients on effective therapy are eligible, as are those who've been cured of hepatitis C. Participants must agree to use contraception.

Inclusion Criteria

I've had limited treatment with hydroxyurea, cytarabine, or a TKI for less than 30 days.

I had hepatitis C but have been treated and cured.

My heart function is classified as class II or better according to NYHA.

Exclusion Criteria

Patients who are receiving any other investigational agents

Active autoimmune disease at screening

I do not have any uncontrolled conditions or active infections, including hepatitis B or C.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Dasatinib and Ropeginterferon to assess molecular response and safety

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 years

What Are the Treatments Tested in This Trial?

Interventions

• Dasatinib
• Ropeginterferon alfa-2b

Trial Overview The trial is testing the combination of Dasatinib plus Ropeginterferon alfa-2b for treating Chronic Myeloid Leukemia in chronic phase. It aims to see if this drug combo controls the disease better and what side effects it might cause.

How Is the Trial Designed?

Group I: Phase 2 Treatment with Dasatinib (PO) + Ropeginterferon (SC) Experimental Treatment 2 Interventions

Participants will receive treatment on an outpatient basis.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27133821/

Safety and efficacy of the combination of pegylated ... Dasatinib (DAS) and interferon-α have antileukemic and immunostimulatory effects and induce deep responses in chronic myeloid leukemia (CML).

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07269470

NCT07269470 | Phase II Study Assessing the Safety and ... The goal of this clinical research study is to find out if treatment with a combination of dasatinib plus ropeginterferon can help to control CML-CP. The safety ...

3. ashpublications.org ashpublications.org/blood/article/126/23/134/104486/Combination-of-Dasatinib-and-Peg-Interferon-Alpha

Combination of Dasatinib and Peg-Interferon Alpha 2b in ... Eight serious AE (SAE) were reported after Peg-IFNa2b initiation: G4 neutropenia n=2, dysthyroitidis n=1, dyspnea n=1, pleural effusion n=1, ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36214090/

Dasatinib plus Peg-Interferon alpha 2b combination in ... This study investigated the efficacy and safety of dasatinib combined to Peg-IFN-α2b (Dasa-PegIFN, NCT01872442).

5. hematologyadvisor.com hematologyadvisor.com/news/chronic-myeloid-leukemia-cml-dasatinib-peg-ifn-alpha2b-safe-effective/

Dasatinib Plus Peg-IFN-Alpha2b Appears Safe, Effective in ... Researchers determined combining dasatinib and Peg-IFN-alpha2b may be an effective method for inducing DMRs in newly diagnosed CML.

6. ashpublications.org ashpublications.org/blood/article/126/23/477/93221/Safety-and-Efficacy-of-Addition-of-Pegylated

Safety and Efficacy of Addition of Pegylated Interferon alpha2b ... Safety and Efficacy of Addition of Pegylated Interferon alpha2b to Standard Dose Dasatinib in Newly Diagnosed Chronic Phase CML Patients ...